Development and validation of nystatin potency assay using solvent dimethyl sulfoxide
YU Hai-bing
XIE Wei-guo
CHU Zhi-gang
RUAN Qiong-fang
LI Hua-wen
LI Min
DING Yuan-ling
KONG Dan-li
Paul Yao
Abstract：Objective To investigate the feasibility of dimethyl sulfoxide (DMSO) instead of N,N-dimethyl formamide (DMF) as a solvent for the nystatin potency assay.Methods Nystatin was dissolved in DMSO or DMF,and its potency was determined using antibiotic microbial assay of the United States Pharmacopeia (USP).Results Both DMF and DMSO methods had satisfied accuracy,precision,specificity,linear range (10.0-40.0 U/mL),limit of detection (2.0 U/mL) and robustness.Meanwhile,DMSO method has higher sensitivity and lower limit of quantitation (LOQ,3.0 U/mL) than DMF method.Conclusion Since DMSO has much less toxicity than DMF,and DMSO method has equivalent or even better analytical performance characteristics than DMF method,DMSO may be a good candidate to replace DMF as the solvent for the determination of nystatin activity.
Keywords：nystatinpotency assaydimethyl sulfoxideNN-dimethyl formamide
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：9( 241-249 )